Efferalgan 150mg

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Efferalgan 150mg

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Overview of Efferalgan 150mg

Quick Facts

Property Description
Active ingredient Paracetamol (Acetaminophen)
Form Effervescent Tablet or Powder
Pharmacological class Non-opioid Analgesic and Antipyretic
Common use Symptomatic relief of pain and fever
Origin Synthetic anilide derivative

Classification and Core Identity of Efferalgan 150mg

Efferalgan 150mg is a specific pharmaceutical preparation recognized primarily as a non-opioid analgesic and antipyretic medicine. This entity is defined by its sole active ingredient, Paracetamol, which is also known globally as Acetaminophen. Paracetamol is recognized as an essential medicine due to its established importance and broad utility in managing fundamental symptoms. The central purpose of this medication is to provide general, symptomatic relief for symptoms like a minor headache or a raised temperature. It achieves this by acting centrally within the Central Nervous System (CNS) to modify the body's response to painful stimuli and regulate temperature.


Composition, Form, and Origin

The core composition of Efferalgan 150mg consists of the single-ingredient Paracetamol, a synthetic anilide derivative. The Efferalgan brand specifically focuses on effervescent presentations, which are distinct from standard tablets as they require dissolution in liquid before being taken orally. This particular dosage strength of 150 milligrams (mg) is designed for accurate proportional dosing, making it a key formulation for the pediatric patient group, often for use by children aged 3 to 10 years. Paracetamol is a recognized first-line non-opioid analgesic for mild to moderate pain, used for managing everyday discomfort and fever, with its effervescent form offering an alternative to solid tablets.


How Does Paracetamol Provide General Relief?

Paracetamol provides general relief by directly influencing the body's internal systems responsible for maintaining temperature and sensing pain. The mechanism involves the modulation of chemical pathways that affect the hypothalamic heat-regulating center in the brain, which effectively helps to "reset" the body’s temperature during fever, and simultaneously contributes to the elevation of the pain threshold. This action contrasts with that of traditional anti-inflammatory drugs, such as NSAIDs, because Paracetamol does not exert significant peripheral anti-inflammatory effects, focusing its action on the perception of discomfort rather than localized inflammation.

Regulatory References

  1. NIH MedlinePlus
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What side effects are possible with Efferalgan 150mg?

Possible Side Effects and Safety Information

Official regulatory documents classify the safety profile of this medicine primarily by affected body systems, documented adverse reaction frequencies, and specific limitations on use.


Adverse Reactions

Adverse reactions are documented across several System-Organ Classes, including Blood and Lymphatic System Disorders, Immune System Disorders, Hepatobiliary Disorders, and Skin and Subcutaneous Tissue Disorders.

Frequency Classification Documented Examples
Rare (1-10 per 10,000 users) Thrombocytopenia (low platelet count), hepatic function abnormalities, agranulocytosis (reduction in white blood cells), and non-severe hypersensitivity reactions.
Very Rare (Fewer than 1 per 10,000 users) Severe cutaneous reactions, including Stevens-Johnson syndrome and Toxic Epidermal Necrolysis; anaphylaxis; pancreatitis; and neutropenia.
Not Known (Cannot be estimated) Anaphylactic shock, angioedema (swelling beneath the skin), and high anion gap metabolic acidosis.

Serious Adverse Reactions and Restrictions

Serious Adverse Reactions highlighted in regulatory sources include fatal liver damage resulting from overdose, severe anaphylactic shock, and life-threatening severe skin reactions.

Safety-Related Restrictions and Limitations define conditions where use is contraindicated or requires specific caution:

  • Contraindications include severe hepatocellular insufficiency, active liver disease, and severe haemolytic anemia.
  • Caution is advised for patients with severe renal impairment (kidney disease), severe hepatic impairment, chronic alcoholism or excessive alcohol intake, and conditions leading to chronic malnutrition or dehydration.
  • The stated maximum daily dose must not be exceeded, as ingesting doses higher than recommended carries a substantial risk of very serious liver damage. Additionally, concomitant use of other products containing the same active substance must be avoided to prevent accidental overdose.
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Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Efferalgan 150mg (Paracetamol) overdose is defined by the critical risk of delayed hepatotoxicity (severe liver damage), which can lead to acute liver failure. Initial, non-specific manifestations documented in official labeling include nausea, vomiting, abdominal pain, and general fatigue. Severe, later-stage outcomes may involve confusion, jaundice, and potential secondary effects on the renal system, ultimately risking death or the need for liver transplantation.

Immediate Emergency Action: Urgent medical help must be sought right away upon any suspected overdose, regardless of whether symptoms are present, as the most severe damage is often initially silent. If an overdose is confirmed or suspected, contact emergency services or a Poison Control Center immediately.

Official Management Protocol: The specific antidote, N-acetylcysteine (NAC), is mandated for treatment and is most effective when administered within eight hours of ingestion. Overdose management is officially defined by mandatory hospital monitoring and continuous clinical and laboratory testing of serum Acetaminophen concentration against a standard nomogram. Individuals with pre-existing liver disease or chronic alcohol consumption are explicitly noted in regulatory documents as having an increased susceptibility to severe toxicity.

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Therapeutic Uses of Efferalgan 150mg

What Efferalgan 150mg Treats: Main Uses and Benefits

Efferalgan 150mg is applied across domains where additional symptomatic support is needed, primarily as an antipyretic to help ease systemic temperature elevation. The medication is commonly used in conditions characterized by periods of heightened symptoms, such as fever associated with common infections or following routine immunizations. It also supports symptom management by contributing to the relief of mild to moderate acute and episodic discomforts, including headache, toothache, and musculoskeletal aches.

The core benefit is that this symptomatic relief contributes to improved comfort during difficult episodes. This is especially relevant in clinical settings that involve acute or unstable symptom patterns. The medication is generally applied in settings where short-term symptomatic assistance is needed, offering support that helps ease the overall symptom burden.

Quick Fact: Relief for Pain and Fever
Primary action Antipyretic (Fever Reduction) and Analgesic (Pain Relief)
Symptom Level Mild to Moderate
Common Contexts Colds, flu-like syndromes, post-immunization discomfort

Regulatory References

  1. NIH's comprehensive overview on Acetaminophen
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Eligibility and Restrictions for Use

Official Eligibility and Contraindications

Efferalgan 150mg is a specific strength primarily reserved for use in children within a defined weight range, typically between mathbf8 kg and mathbf13 kg (approximately 6 months to 2 years), as documented in regulatory information. Use in children weighing less than 8 kg is generally not recommended.

Classification Population/Condition Restriction Detail
Contraindicated Severe hepatocellular impairment or active decompensated liver disease Prohibited due to the risk of severe toxicity [Source 1.1].
Hypersensitivity to Paracetamol or excipients Prohibited (Absolute Non-Eligibility) [Source 1.1].
Hereditary Fructose Intolerance Prohibited if formulation contains sorbitol [Source 1.1].
Conditional Use Mild to moderate hepatic impairment or Gilbert's syndrome Requires caution and may necessitate dose adjustment [Source 1.2].
Renal impairment or Chronic Malnutrition Requires caution and may necessitate prolonged dosing intervals [Source 1.1].
Pregnancy and Lactation Permitted when clinically necessary at the lowest effective dose for the shortest duration [Source 4.4].

The eligibility profile is structured by weight-dependent approval for pediatrics and absolute exclusions for severe liver conditions. Use during pregnancy and breastfeeding is generally permitted under caution, while conditions affecting clearance, such as renal or milder hepatic impairment, require special consideration for administration.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information describes interactions primarily through pharmacokinetic changes and pharmacodynamic amplification of co-administered medicines.

Pharmacokinetic and Exposure-Altering Interactions

  • Clearance and Metabolism: Co-administration with Probenecid formally reduces Paracetamol clearance by inhibiting the conjugation process, which can increase plasma levels. Conversely, Enzyme-Inducing Agents (e.g., Phenytoin, Carbamazepine, Rifampicin), St. John’s Wort, and chronic alcohol consumption are officially associated with an increased metabolism of Paracetamol, increasing the risk of liver damage when combined at maximum therapeutic doses.
  • Absorption Rate: Agents such as Metoclopramide and Domperidone accelerate the absorption of Paracetamol. In contrast, Cholestyramine reduces absorption, leading to a specific timing rule that mandates separation of administration by at least one hour.

Pharmacodynamic and Risk Interactions

  • Anticoagulants: Prolonged, regular daily use of Paracetamol officially enhances the anticoagulant effect of Vitamin K antagonists (e.g., Warfarin), carrying an increased risk of bleeding. Occasional doses are noted to have no significant effect.
  • Toxicity Risk: Concurrent use with Flucloxacillin is formally associated with an increased risk of high anion gap metabolic acidosis (HAGMA) in the presence of specific risk factors. Population-specific risk factors, including hepatic impairment, severe renal impairment, and chronic alcoholism, are officially listed as increasing the hazard of toxicity during co-administration with interacting agents.
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Mechanism of Action

The mechanistic activity of Efferalgan 150mg is concentrated within the Central Nervous System ( CNS) . Its primary interaction involves acting as an indirect inhibitor of the Cyclooxygenase ( COX) enzyme system within the brain and spinal cord, specifically targeting the enzyme's peroxidase ( POX) site. This interaction reduces the intracellular synthesis of the signaling mediator Prostaglandin E2 ( PGE2). A secondary mechanism involves the active metabolite, N-(4-hydroxyphenyl)arachidonoylamide ( AM404). This metabolite modulates activity within the endocannabinoid system and acts as an agonist for TRPV1 receptors in the CNS. The combined mechanistic cascade influences hypothalamic thermoregulatory signaling and reinforces descending inhibitory pathways, thereby modulating the central processing of nociception. This focused central activity shapes the drug's effect profile.

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Dosage and Administration Information

How to Use Efferalgan 150mg

Efferalgan 150mg is a dosage strength of Paracetamol reserved for use in the pediatric population. Administration is based on protocols determined by body weight, not age. The formulations typically available in this strength are suppositories for rectal use or effervescent powder for oral use.


Official Administration Guidelines

Feature Official Protocol
Route of Administration Oral (for effervescent powder, dissolved in water) or Rectal (for suppositories).
Dosing Principle Dosing is based on the child's body weight (kg), with the general dose being approximately 15 mg/ kg per administration.
Dose Unit and Range One 150 mg unit (sachet or suppository) is the standard dose per administration for children within the designated weight range (e.g., 8 kg to 13 kg).
Minimum Interval The minimum time interval between doses must be at least 6 hours to ensure safe total daily intake.
Maximum Daily Limit The total daily dose should not exceed the established limit, typically 60 mg/ kg/ day.
Preparation The effervescent powder must be completely dissolved in a glass of water before it is taken orally.

Procedural Context and Adjustments

Administration involves selecting the correct dosage unit based on the child's actual body weight and adhering to the mandated 6-hour minimum interval between doses. Regular administration, including at night, helps to maintain consistent dosing. For patients identified with severe renal impairment (creatinine clearance < 10 mL/ min), the minimum interval between administrations must be extended to at least 8 hours. Rectal administration should be kept as short as possible due to the risk of local irritation.

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Recent Clinical Evidence

Research evidence / Overview of studies for Efferalgan 150mg

This overview summarizes the types of authoritative research and clinical trials that have examined Paracetamol, the active ingredient in Efferalgan 150mg, focusing on what was studied and what remains uncertain, without providing any medical advice.


Evidence for Symptom Management of Fever (Antipyresis)

Research for this use primarily includes Randomized Controlled Trials (RCTs) and systematic reviews that explored how symptoms change over time in children. Studies focused on measuring outcomes related to systemic imbalance, specifically the degree of temperature change over defined time intervals. The findings describe patterns observed in children and infants who were experiencing conditions involving periods of heightened symptoms. Reported measurements were observed to focus on short-term physiological responses, typically tracked across the initial 48 hours following the dose.

However, the existing studies provide limited information for long-term outcomes, particularly those related to repeated use over prolonged periods. Additionally, findings were mixed and highly variable in how they captured subjective patient-reported outcomes, limiting the ability to synthesize findings about these specific axes.


Evidence for Relief of Mild-to-Moderate Acute Episodic Pain (Analgesia)

The active ingredient was evaluated in research exploring outcomes related to physical discomfort in contexts involving acute or disruptive episodes. Research examined patient-reported outcomes describing perceived discomfort and the proportion of children who met a pre-specified threshold for symptom change. These findings describe group patterns related to how symptoms changed in the observed populations across short-term use.

Follow-up durations were limited in these acute pain trials, meaning that limited information is available regarding the effects of repeated administration or use that extends beyond the initial few days. The trials were restricted to pain categorized as mild to moderate; comparative evidence for certain subgroups remains insufficient.


Evidence Gaps and Areas of Uncertainty

One primary limitation is the complete absence of dedicated randomized controlled trials to assess the use of Paracetamol for chronic non-cancer pain in pediatric populations. For this specific context, the certainty remains low, and current treatment approaches are not derived from structured trial evidence.

In general, heterogeneity is observed across studies, particularly in how they measure subjective patient-reported outcomes, leading to high variability in reported findings. Research provides context but not individual predictions, and the findings describe group patterns, not personal outcomes.

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Frequently Asked Questions (FAQ)

Common questions about Efferalgan 150mg (FAQ)

Q: How is Efferalgan 150mg different from other paracetamol products available?

Official product information indicates that Efferalgan 150mg is distinct due to its formulation, typically supplied as an effervescent powder or suppository. These specific forms are created to suit the needs of the pediatric population. The 150mg strength is designed for precise, proportional dosing based on the child's body weight as defined by regulatory protocols.

Q: What specific types of pain is this medicine indicated to treat?

The active ingredient is officially indicated for the general symptomatic relief of fever and episodes of mild to moderate acute pain. This typically includes common discomforts like minor headache, toothache, and general aches associated with common cold symptoms. Regulatory information and available studies describe how symptoms change across short-term use.

Q: Does the 150mg formulation work differently than a higher strength like 500mg?

The core active ingredient and its fundamental mechanism of action are considered the same, regardless of the dose unit. The different strengths represent an administrative difference designed to facilitate the exact proportional mg/ kg dosing required for the pediatric patient group.

Q: Why is Efferalgan 150mg available in a suppository or effervescent powder form?

Regulatory documents explain that these forms are primarily chosen to make the medicine easier to administer to children. The suppository form can be beneficial in situations where a child is unable to swallow an oral medication or when they are experiencing vomiting.

Q: How long does it typically take for Efferalgan 150mg to start reducing a fever?

According to regulatory pharmacokinetic data, the active ingredient typically begins to reach its maximum concentration in the bloodstream within 30 minutes to 1 hour after being taken orally. This time frame generally aligns with when the fever-reducing effect may begin.

Q: What is the expected duration of effect after a single dose?

The regulatory guidelines for safe administration require a minimum time interval of at least 6 hours between doses for those with normal kidney function. The mandated interval is established based on the time required to safely clear the medicine from the system, which informs the expected duration of the effect.

Q: Are there any foods or drinks that should be avoided when giving this medicine?

Regulatory information advises against use with chronic alcohol consumption due to the increased risk of liver damage. Official documents also note that while certain foods do not need to be strictly avoided, taking the medicine with food may delay its absorption and the onset of its effect.

Q: What is the reason for the minimum time interval required between administrations?

The mandated minimum interval of at least 6 hours is put in place by regulatory bodies to ensure that the drug has sufficient time to be processed and cleared from the body. Adhering to this timing is necessary to avoid exceeding the maximum daily dose, as cumulative high doses carry a substantial risk of liver toxicity.

Q: Does using the suppository route change how quickly the medicine is absorbed?

According to regulatory pharmacokinetic studies, the absorption rate of the active ingredient varies depending on the route of administration. Rectal administration (suppository) is generally described as being slower and more variable compared to the absorption achieved through the oral route (effervescent powder).

Q: What physical signs should a parent look for to know the medicine is starting to work?

Official information states that the medicine works to reduce temperature and alleviate discomfort. Observable signs that the medicine is starting to work are consistent with symptom improvement, such as the child appearing more settled, less irritable, or resting comfortably, which indicates a reduction in pain or fever.

Q: What are the most commonly reported side effects of paracetamol in children?

Regulatory safety documents primarily classify the reported adverse reactions as rare or very rare. When this medicine is used strictly according to the recommended dose and intervals, official information indicates that common adverse events are limited or are not consistently classified in regulatory lists.

Q: What are the potential signs of a serious allergic reaction to Efferalgan 150mg?

Official product warnings highlight the potential for severe hypersensitivity reactions, including anaphylaxis and angioedema (swelling beneath the skin). Signs that may be observed in such severe reactions can include swelling of the face, throat, or tongue, and difficulty breathing.

Q: Can paracetamol potentially cause stomach upset or digestive issues?

While the adverse reaction profile lists some gastrointestinal issues, such as the very rare occurrence of pancreatitis, general stomach upset is not typically classified as a common side effect for this medicine in regulatory documents, unlike other classes of pain relievers.

Q: Does Efferalgan 150mg typically cause drowsiness or sleepiness?

The regulatory profile of this medicine, which details expected and reported side effects, typically does not list drowsiness or sedation as an adverse reaction.

Q: What are the non-specific warning signs associated with paracetamol overdose?

According to regulatory documents, early signs that may indicate an overdose include non-specific symptoms such as nausea, vomiting, loss of appetite, and abdominal pain. These symptoms, which may precede signs of serious liver damage, should be immediately reported to a healthcare professional.

Q: What is the potential long-term risk associated with taking paracetamol for many days?

Official regulatory warnings caution against prolonged or repeated use of the active ingredient without medical supervision. Regulatory warnings indicate this is due to the potential risk of renal (kidney) toxicity and the risk of severe liver damage associated with cumulative high doses.

Q: Can Efferalgan 150mg be used in children who have a known kidney condition?

Regulatory documents advise caution when the medicine is used in patients with existing renal (kidney) impairment. For severe kidney conditions, the official guidelines mandate that the minimum interval between doses must be extended to at least 8 hours to ensure the medicine is cleared safely.

Q: Are there specific warnings for individuals with G6PD deficiency?

Official regulatory warnings advise caution when administering this medicine to individuals diagnosed with Glucose-6-phosphate dehydrogenase (G6PD) deficiency. This is due to the potential risk of haemolytic anemia, which is a condition involving the destruction of red blood cells.

Q: What is the reason the suppository form is not recommended for children with diarrhea?

The suppository form is officially discouraged for use when a child is experiencing diarrhea. This is due to regulatory concerns that the diarrhea may impair the retention of the suppository and therefore reduce the absorption of the active ingredient, potentially making the dose less effective.

Q: Is this medicine known by a different generic or brand name in countries like the US?

The active substance in this medicine, Paracetamol, is widely known as Acetaminophen in other countries, including the United States. This generic substance is then sold under various brand names globally.

Q: What types of other medicines commonly contain paracetamol as an active ingredient?

Regulatory sources specifically warn against using this medicine concurrently with combination cold, cough, and flu products. This is because these common over-the-counter medicines frequently contain the same active ingredient, Paracetamol, which can unintentionally increase the risk of accidental overdose.

Q: Can I safely give my child Efferalgan 150mg if they are also taking cold medication?

Official regulatory warnings strictly state that concomitant use of other products containing paracetamol must be avoided. Official warnings emphasize avoiding co-administration to ensure the maximum safe daily limit is not exceeded, given the associated risk of severe toxicity.

Q: Does Efferalgan 150mg interact with any commonly prescribed antibiotics?

Regulatory documents mention specific interactions with the antibiotic Flucloxacillin. Official warnings note that using these two medicines together is associated with an increased risk of high anion gap metabolic acidosis (HAGMA) in individuals with specific risk factors.

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How should Efferalgan 150mg be stored and disposed of?

Official Storage and Disposal Requirements

This section details the mandatory storage, stability, and disposal instructions for Efferalgan 150 mg, as specified in regulatory labeling.

Storage Requirement Specification from Regulatory Sources
Temperature Store at a temperature below 25 C or up to 30 C
Protection Must be kept in the original outer packaging to protect from moisture and light
Child Safety Keep out of the sight and reach of children
Stability Limit Do not use the medicine after the expiry date printed on the package

For disposal, do not throw away medicines via wastewater or household waste to protect the environment. Unused or expired products should be disposed of by consulting a pharmacist or using an authorized drug take-back program.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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